BlueCross BlueShield of Tennessee Medical Policy Manual

End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema

DESCRIPTION

End-diastolic pneumatic compression fluid (e.g. The Circulator Boot™, Multicrus Circulator Boot™) has been investigated in the treatment of peripheral vascular disease, venous stasis, and lymphedema. Timed, sequential inflation during the end-diastolic portion of the cardiac cycle is applied to a boot enclosing the foot or ankle, or extending from the toes to the groin, and is designed both to allow maximal arterial flow into the leg and to expel venous blood and lymphatic. Therapy is typically offered in a series of 40-minute sessions in an office setting. The end-diastolic compression device is distinctly different from single and multi-chambered lymphedema devices (used in the presence of significant lymphedema) and intermittent compression pumps (used for DVT prevention). The latter 2 devices do not require synchronization with the cardiac cycle; whereas the end diastolic pump relies on EKG input to apply timed compression just prior to the next QRS complex thereby reducing afterload and cardiac work. This same synchronized compression technology is used under direct supervision by a physician to increase cardiac output, and in that setting is known as enhanced external counterpulsation.

The end-diastolic pneumatic compression boot includes the following components: a heart monitor to detect the QRS complex of the electrocardiogram (EKG) and to appropriately time boot compressions in the end portion of the heart cycle; a rapid action valve assembly capable of both pressurizing and exhausting the boots; rigid, adjustable long boots to enclose the leg from groin to toes; and double-walled plastic bags to enclose the treated portion of the leg and to contain the compressed air.

NOTE: Lymphedema devices, intermittent compression pumps and enhanced external counterpulsation intended to treat decreased cardiac output are NOT addressed by this policy.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

Well-designed studies, which evaluate the clinical importance of end-diastolic pneumatic compression devices for the treatment of vascular disease and related conditions, continue to be lacking. The available evidence is small case series which are outdated, and no randomized controlled trials are available regarding this technology.

SOURCES

Dillon, R.S. (1980). Effect of therapy with the pneumatic end-diastolic leg compression boot on peripheral vascular tests and on the clinical course of peripheral vascular disease. Angiology, 31 (9), 614-638. Abstract retrieved July 8, 2019 from PubMed database.

Dillon, R.S. (1986). Successful treatment of osteomyelitis and soft tissue infections in ischemic diabetic legs by local antibiotic injections and the end-diastolic pneumatic compression boot. Annals of Surgery, 204 (6), 643-649. (Level 4 evidence)

Dillon, R.S. (1997). Fifteen years of experience in treating 2177 episodes of foot and leg lesions with the circulator boot. Results of treatments with the circulator boot. Angiology, 48 (5 Pt 2), S17-S34. Abstract retrieved July 8, 209 from PubMed database.

Flip, J.R., & Dillon, R.S. (2008). Treatment of end-stage “trash feet” with the end-diastolic pneumatic boot. Angiology, 59 (2), 214-219. Abstract retrieved July 8, 2019 from PubMed database.

U. S. Food and Drug Administration (2009, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082134. Retrieved April 18, 2011 from http://www.accessdata.fda.gov. 

Vella, A., Carlson, L.A., Blier, B., Felty, C., Kuiper, J.D., & Rooke, T.W. (2000). Circulator boot therapy alters the natural history of ischemic limb ulceration. Vascular Medicine, 5 (1), 21-25. Abstract retrieved July 8, 2019 from PubMed database.

ORIGINAL EFFECTIVE DATE: 1/1/2005

MOST RECENT REVIEW DATE:  8/8/2019         

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